Trial Outcomes & Findings for Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism (NCT NCT03878108)

NCT ID: NCT03878108

Last Updated: 2021-06-03

Results Overview

Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2021-06-03

Participant Flow

Participant milestones

Measure	LCHF Diet Then LFHC Diet Low carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet	LFHC Diet Then LCHF Diet Low fat, high carbohydrate diet (LFHC) diet then low carbohydrate, high fat (LCHF) diet
Overall Study STARTED	11	10
Overall Study Completed First Phase	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	LCHF Diet Then LFHC Diet Low carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet	LFHC Diet Then LCHF Diet Low fat, high carbohydrate diet (LFHC) diet then low carbohydrate, high fat (LCHF) diet
Overall Study Adverse Event	1	0

Baseline Characteristics

Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism

Baseline characteristics by cohort

Measure	LCHF Diet Then LFHC Diet n=11 Participants Low carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet	LFHC Diet Then LCHF Diet n=10 Participants Low fat, high carbohydrate diet (LFHC) diet then low carbohydrate, high fat (LCHF) diet	Total n=21 Participants Total of all reporting groups
Age, Continuous	28.7 Years STANDARD_DEVIATION 7.1 • n=5 Participants	31.6 Years STANDARD_DEVIATION 5.5 • n=7 Participants	30.1 Years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.

Outcome measures

Measure	LC Diet n=20 Participants Low carbohydrate diet	LF Diet n=20 Participants Low fat diet
Ad Libitum Energy Intake	2752 kcal per day Standard Error 52.0	2063 kcal per day Standard Error 52.0

SECONDARY outcome

Timeframe: Day 14

An OGTT was performed at the end of each 14 day period and the mean glucose was calculated

Outcome measures

Measure	LC Diet n=20 Participants Low carbohydrate diet	LF Diet n=20 Participants Low fat diet
Mean Glucose During Oral Glucose Tolerance Test (OGTT)	115.6 mg/dl Standard Error 2.9	143.3 mg/dl Standard Error 2.9

SECONDARY outcome

Timeframe: Baseline and day 14

Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)

Outcome measures

Measure	LC Diet n=20 Participants Low carbohydrate diet	LF Diet n=20 Participants Low fat diet
Change in Body Weight	1.77 kg Standard Error 0.32	1.09 kg Standard Error 0.32

SECONDARY outcome

Timeframe: Baseline and day 14

Change in body fat mass from baseline to day 14 for each diet, measured in kilograms (kg). Body fat mass was measured using Dual-energy X-ray absorptiometry (DXA) measurements.

Outcome measures

Measure	LC Diet n=20 Participants Low carbohydrate diet	LF Diet n=20 Participants Low fat diet
Change in Body Fat Mass	-0.18 kg Standard Error 0.19	-0.67 kg Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline and day 14

Change in cholesterol from baseline to day 14 for each diet

Outcome measures

Measure	LC Diet n=20 Participants Low carbohydrate diet	LF Diet n=20 Participants Low fat diet
Change in Cholesterol	-1.25 mg/dl Standard Error 5.47	-41.75 mg/dl Standard Error 5.47

SECONDARY outcome

Timeframe: Baseline and day 14

Change in triglycerides from baseline to day 14 for each diet

Outcome measures

Measure	LC Diet n=20 Participants Low carbohydrate diet	LF Diet n=20 Participants Low fat diet
Change in Triglycerides	-12.1 mg/dl Standard Error 6.4	17.9 mg/dl Standard Error 6.4

SECONDARY outcome

Timeframe: Baseline and day 14

Change in thyroid stimulating hormone (TSH) from baseline to day 14 for each diet

Outcome measures

Measure	LC Diet n=20 Participants Low carbohydrate diet	LF Diet n=20 Participants Low fat diet
Change in TSH	0.082 uIU/ml Standard Error 0.176	-0.403 uIU/ml Standard Error 0.176

SECONDARY outcome

Timeframe: Baseline and day 14

Change in C-peptide from baseline to day 14 for each diet

Outcome measures

Measure	LC Diet n=20 Participants Low carbohydrate diet	LF Diet n=20 Participants Low fat diet
Change in C-peptide	-0.610 ng/ml Standard Error 0.080	-0.250 ng/ml Standard Error 0.080

SECONDARY outcome

Timeframe: Baseline and day 14

Change in C-reactive protein (CRP) from baseline to day 14 for each diet

Outcome measures

Measure	LC Diet n=16 Participants Low carbohydrate diet	LF Diet n=15 Participants Low fat diet
Change in CRP	0.068 mg/l Standard Error 0.289	-0.842 mg/l Standard Error 0.296

Adverse Events

LC Diet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

LF Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	LC Diet n=21 participants at risk Low carbohydrate diet	LF Diet n=20 participants at risk Low fat diet
Metabolism and nutrition disorders Hypoglycemia	4.8% 1/21 • Number of events 1 • During each 14 day diet period	0.00% 0/20 • During each 14 day diet period

Additional Information

Kevin Hall, PhD

NIDDK

Phone: 301-402-8248

Email: kevin.hall@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place